FDA label 951b0171-8b55-967d-e053-2a95a90a17e1

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
aeb7f1b6-edf1-45b7-9bc8-903b3b29b52d
SPL ID
951b0171-8b55-967d-e053-2a95a90a17e1
Version
8
Effective date
2019-10-17
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:55

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert : Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other ‘caine’ anesthetics. Sore t hroat w arning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAIO, ask a doctor or pharmacist before taking the product. Ask a doctor before use if you have cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days, irritation, pain or redness persists or worsens. swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or presistent headache. These could be signs of a serious illness. If pregnant or breast feeding ask a health professional before use. Keep this and all drugs out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.